FDA says some young children may not get updated COVID booster until next year

Nearly all Americans will be eligible to receive a dose Updated COVID-19 VaccinesThat followed a decision to expand the emergency use authorization for Moderna and Pfizer-BioNTech’s shots to most children through the age of 6 months.

The Food and Drug Administration announced expanded authorization Thursday, clearing all recipients of Moderna’s COVID-19 vaccine to receive booster doses from the company’s latest “bivalent” vaccines — which correspond to the recent Omicron variant – At least two months after their last “monovalent” shot.

But only some of the youngest children to get Pfizer-BioNtech’s shots will be eligible to get a shot of its updated COVID vaccine this year.

The FDA had previously green-lighted Pfizer’s shots as a three-dose “primary series” in this age group, after data showed children ages 6 months to 4 years to get protection equivalent to adults after two doses and a third. Child-sized doses were needed.

Now the FDA says that only children who have not yet completed their third dose can swap out the last shot for the updated vaccine. Early adopters who already completed their third shot a few months ago should wait until the FDA receives more data next year.

In a statement, the FDA said, “Data for prescribing an updated bivalent booster dose for these children is expected in January. The agency remains committed to evaluating those data as soon as possible.”

The agency said it expected children in this age group would still be “protected from the most severe consequences” from the current variant.

“At this time, we do not have clinical data in this age group for the fourth (booster) dose of the original vaccine following the third primary series dose,” Pfizer spokeswoman Julia Mitchell Cohen said in an email. Can’t extrapolate.” ,

The final hurdle in clearing shots designed for the youngest children will come from the Centers for Disease Control and Prevention.

“We are aware of the FDA authorization and the next step is a review of the CDC data before the shots can be made available to children,” CDC spokeswoman Kristen Nordlund said in an email.

Nordlund did not say whether the agency plans to consult its outside vaccine advisors before a decision, as it has for some recent booster eligibility extensions.

Jurisdictions this week wrapped up pre-orders for updated bivalent shots for the youngest children earlier this week, according to planning documents published by the CDC. There will be an “ample but limited supply” of shots available, the agency said.

Only a small fraction of the updated COVID-19 vaccines purchased by the Biden administration from Pfizer and Moderna have been updated.

Fewer than 15% of Americans age 5 and older who were previously eligible to receive an updated booster have received one so far. Less than a third of seniors – the most vulnerable age group – have received the new shot, which first rolled out in September.

Among children under the age of 5, less than 5% have completed their primary series of COVID vaccinations.

“I think the uptake has been pretty slow,” the CDC’s Barbara Mahone, chief of the agency’s proposed coronavirus and other respiratory viruses division, said at a meeting Wednesday.

Mahon said more changes could be coming soon.

US health officials first plan to switch all COVID-19 vaccines to the bivalent formulation, as regulators in Europe recently decided to allow. CDC officials have said the change will be necessary because the US stock of the monovalent vaccine is about to run out.

Mahon said, “We also look forward to many upcoming policy discussions regarding the use of booster and bivalent vaccines in children under 5 years of age, and the transition of the primary series from monovalent to bivalent COVID 19 vaccines Guessing.”

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